CompletedPhase 1

ORIOn-E: A Study Evaluating CPI-1205 in Patients With Advanced Solid Tumors

United States24 participantsStarted 2017-12-14

Plain-language summary

This is a Phase 1/2, multi-center, open-label study of CPI-1205 + ipilimumab in patients with histologically or cytologically confirmed advanced solid tumors. This study is designed to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of CPI-1205 + ipilimumab in patients with advanced solid tumors. Patients in Phase 2 will be treated at the RP2D of CPI-1205 + ipilimumab. This study was stopped prior to proceeding to Phase 2; no patients were enrolled in Phase 2.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Relapsed following or progressed through standard therapy
✓. Have a disease for which no standard effective therapy exists (i.e., a therapy that demonstrates a significant increase in survival)
✓. Not a candidate for standard effective therapy NOTE: In men with prostate cancer, baseline testosterone levels must also be ≤50ng/dL (≤ 2.0nM) and surgical or ongoing medical castration must be maintained throughout the duration of the study.
✓. Cohort A: unresectable or metastatic melanoma
✓. Cohort B: metastatic NSCLC
✓. Cohort C: advanced or metastatic (stage 4) RCC
✓. Cohort D: unresectable or metastatic urothelial carcinoma (urethra, bladder, ureters, or renal pelvis)

What they're measuring

Phase 1: Frequency of Dose-limiting toxicities (DLTs)

Timeframe: 1 year

Phase 2: Objective response rate

Timeframe: 1 year

Trial details

NCT IDNCT03525795

SponsorConstellation Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-06-12

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